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. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

Goldenberg 1996.

Study characteristics
Methods Design: cross‐over
Duration: 6 weeks
Assessment: baseline and post‐intervention
Country: USA
Participants Pain condition: fibromyalgia
Population: adults with fibromyalgia
Minimum pain intensity: ≥ 30 on 0‐100 VAS
Inclusion criteria
  • Aged 18‐60

  • Fibromyalgia that matches ACR criteria

  • ≥ 30 on 0‐100 pain intensity VAS


Exclusion criteria
  • Physical health comorbidities

  • Depression: ≥ 18 on Hamilton Rating Scale for Depression


Total participants randomised: 31
Age in years (mean, SD): 43.2 (9.1)
Gender: 28/31 were female
Pain duration/fibromyalgia symptoms in months (mean, SD): 72.6 (48.1)
Interventions Placebo
  • Inert

  • Double‐dummy design = 2 tablets per day


Amitriptyline 25 mg + placebo
  • TCA

  • Fixed dose

  • Double‐dummy design


Fluoxetine 20 mg + placebo
  • SSRI

  • Fixed dose

  • Double‐dummy design


Amitriptyline 25 mg + fluoxetine 20 mg
  • Combined intervention: TCA + SSRI

  • Fixed doses

  • Double dummy design

Outcomes Pain intensity
Quality of life
Sleep
Mood
Withdrawal
Missing data methods Completer analysis only
Funding source Non‐pharmaceutical: Lot Page Fund, Newton‐Wellesley Hospital, Newton
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomised using a table of random numbers
Allocation concealment (selection bias) Low risk Randomisation and allocation was performed in the hospital pharmacy
Blinding of participants and personnel (performance bias)
All outcomes Low risk Identical tablets and double‐dummy to match dosing schedules across groups
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias)
All outcomes High risk Completer‐only analysis, unequal attrition across arms and high overall dropout
Attrition
Total: 12/31 (38.7%)
Placebo: 1/31 (3.2%)
Amitriptyline 25 mg: 1/31 (3.2%)
Fluoxetine 20 mg: 4/31 (12.9%)
Amitriptyline 25 mg + fluoxetine 20 mg: 5/31 (16.1%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified